Obstetrics risk Assessment: Evaluation of selection criteria for vaccine research studies in pregnant women.

ABSTRACT: Vaccines designed for use in pregnancy and vaccine trials specifically involving pregnant women are rapidly expanding. One of the key challenges in designing maternal immunization trials is that developing exclusion criteria requires understanding and quantifying the background risk for adverse pregnancy outcomes in the pregnancy being studied, which can occur independent of any intervention and be unrelated to vaccine administration. The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project has developed and published case definitions and guidelines for data collection, analysis, and evaluation of maternal immunization safety in trials involving pregnant women. Complementing this work, we sought to understand how to best assess obstetric risk of adverse outcomes a

SUBMITTER: Eckert LO 

PROVIDER: S-EPMC7211583 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature